Home NDC 14498-005-01 STERILE CORD BLOOD COLLECTION UNIT (MSC123D)
Product NDC 14498-005
Requested package NDC 14498-005-01
11-digit product format 144980005
Labeler code 14498
Product ID 14498-005_1a706c96-830f-4446-b640-bbf336364c8a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name anticoagulant citrate phosphate dextrose
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Maco Productions
Application BN125552
Marketing category NDA
Marketing start 2020-10-02
Substance CITRIC ACID MONOHYDRATE; DEXTROSE MONOHYDRATE; SODIUM CITRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
Active strength 114.5; .89; .92; 87.9 g/35mL; g/35mL; g/35mL; g/35mL
Pharmacologic classes Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Additional Listing Data#
Finished product Yes
Brand name base STERILE CORD BLOOD COLLECTION UNIT (MSC123D)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CITRATE .92 g/35mL DEXTROSE MONOHYDRATE .89 g/35mL CITRIC ACID MONOHYDRATE 114.5 g/35mL SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 87.9 g/35mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 14498-005-01 STERILE CORD BLOOD COLLECTION UNIT (MSC123D) 35 mL in 1 KIT INJECTION, SOLUTION 35 5 14498-005-01 STERILE CORD BLOOD COLLECTION UNIT (MSC123D) 1 in 1 KIT INJECTION, SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 14498-005 STERILE CORD BLOOD COLLECTION UNIT (MSC123D) (ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE) INJECTION, SOLUTION [MACO PRODUCTIONS] 4 Current NDC, Legacy NDC, 2 package rows 20241225_e3b456ec-4578-485f-a696-8a343505f30b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 14498-005-01 14498000501 1 KIT in 1 KIT (14498-005-01) / 35 mL in 1 KIT 1 kit 2020-10-02 0000-00-00 No No Current